Registration Dossier
Registration Dossier
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EC number: 902-591-9 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute methanol toxicity in minipigs.
- Author:
- Dorman, D.C. et al.
- Year:
- 1 993
- Bibliographic source:
- Fund Appl Toxicol 20(3): 341-347
Materials and methods
- Principles of method if other than guideline:
- Three animals were used per dose group and treated by gavage with the test substance.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Methanol
- EC Number:
- 200-659-6
- EC Name:
- Methanol
- Cas Number:
- 67-56-1
- Molecular formula:
- CH4O
- IUPAC Name:
- Methyl alcohol
Constituent 1
Test animals
- Species:
- pig
- Strain:
- other: minipig YU, CR
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % - Doses:
- 1000, 2000, 5000 mg/kg bw
- No. of animals per sex per dose:
- 3 females
- Control animals:
- not specified
- Details on study design:
- - Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, histopathology, other: test substance levels and metabolite formation in blood
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Dose-dependent signs of acute intoxication including mild CNS depression, tremor, ataxia, and recumbency, developed within 1.5 to 2 h, and resolved by 52 h.
- Other findings:
- - Histopathology: Methanol- and formate-dosed animals did not develop optic nerve lesions.
- Potential target organs: CNS
- Other observations: Methanol- and formate-dosed animals did not develop toxicologically relevant formate accumulation or metabolic acidosis. Average maximum methanol levels in blood: 3100 ± 700, 6200 ± 2300, and 15200 ± 900 µg/mL, respectively, within 0.5 to 4 h. T/2 ranged from about 9 (low dose) to about 19 and 22 h for the higher doses. Formate plasma levels: transiently 1.74 - 3.4 mEq/L vs. 0.5 ± 0.3 mEq/L (control) within 4 to 30 h post-treatment.
Applicant's summary and conclusion
- Conclusions:
- The minipig, maintained on a normal folate-diet, does not appear to be a satisfactory model for human methanol poisoning.
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